ESD · Hearing Aid, Air-Conduction, Prescription
Ear, Nose, Throat · 21 CFR 874.3300 · Class 1
Overview
| Product Code | ESD |
|---|---|
| Device Name | Hearing Aid, Air-Conduction, Prescription |
| Regulation | 21 CFR 874.3300 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.
Classification Rationale
Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.
Recent Cleared Devices (20 of 1367)
Showing 20 most recent of 1367 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232999 | Lyric4 Hearing Aid | Sonova AG | Apr 11, 2024 | SESE |
| K130790 | LYRIC2 | Phonak, LLC | Jun 27, 2013 | SESE |
| K081136 | LYRIC HEARING AID | Insound Medical, Inc. | May 8, 2008 | SESE |
| K021867 | INSOUND XT SERIES HEARING AID | Insound Medical, Inc. | Nov 19, 2002 | SESE |
| K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Siemens Hearing Instruments, Inc. | Apr 24, 2001 | SESE |
| K984518 | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL | Sonic Innovations, Inc. | Mar 12, 1999 | SESE |
| K974751 | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | General Hearing Instruments, Inc. | Mar 6, 1998 | SESE |
| K974242 | ARGOSY PROGRAMMABLE ONQUE | Argosy Electronics | Jan 20, 1998 | SESE |
| K973880 | SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM | Sonix Technologies, Inc. | Jan 12, 1998 | SESE |
| K974211 | OPUS 2 - FULL CONCHA SERIES - ITE | Bernafon-Maico, Inc. | Dec 15, 1997 | SESE |
| K974152 | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | Bernafon-Maico, Inc. | Dec 15, 1997 | SESE |
| K974069 | OPUS 2 - CANAL SERIES (ITC) | Bernafon-Maico, Inc. | Dec 15, 1997 | SESE |
| K974340 | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | Unitron Industries, Inc. | Dec 12, 1997 | SESE |
| K974339 | UNITRON MODEL SOUND F/XD PROGRAMMABLE | Unitron Industries, Inc. | Dec 12, 1997 | SESE |
| K974338 | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | Unitron Industries, Inc. | Dec 12, 1997 | SESE |
| K974257 | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | Resound Corp. | Dec 12, 1997 | SESE |
| K974129 | HI-69E, HI-69N, HI-69P | Rockwin Corp. | Dec 12, 1997 | SESE |
| K974081 | RESOUND STEALTH CIC | Resound Corp. | Dec 12, 1997 | SESE |
| K973927 | HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL | Hyunjae Corp. | Dec 11, 1997 | SESE |
| K973861 | FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 | Magnatone Hearing Aid Corp. | Nov 19, 1997 | SESE |
Top Applicants
- Unitron Industries, Inc. — 69 clearances
- Miracle-Ear, Inc. — 64 clearances
- Electone, Inc. — 63 clearances
- Oticon Corp. — 54 clearances
- Widex Hearing Aid Co., Inc. — 51 clearances
